Академический Документы
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Auditor(s) __________________________
Does the organization monitor and review information about these external and
internal issues?
Does the organization monitor and review information about these interested
parties and their relevant requirements?
Does the organization apply all the requirements of ISO 9001:2015 if they are
applicable within the scope of the quality management system?
Does the scope state the types of products and services covered, and provide
justification for any requirement of ISO 9001:2015 that the organization
determines is not applicable to the scope of its quality management system?
Has the organization determined the processes needed for the quality
management system and their application throughout the organization, and:
a) determined the inputs required and the outputs expected from these
processes;
b) determined the sequence and interaction of these processes;
c) determined and applied the criteria and methods (including monitoring,
measurements and related performance indicators) needed to ensure the
effective operation and control of these processes;
d) determined the resources needed for these processes and ensure their
availability;
e) assigned the responsibilities and authorities for these processes;
f) addressed the risks and opportunities as determined in accordance with
the requirements of 6.1;
g) evaluated these processes and implement any changes needed to ensure
that these processes achieve their intended results;
h) improved the processes and the quality management system?
4.4.2
As necessary, does the organization:
a) maintain documented information to support the operation of its
processes;
b) retain documented information to have confidence that the processes are
being carried out as planned?
5 Leadership
5.1 Leadership and commitment
5.1.1 General
Does top management demonstrate leadership and commitment with respect to
the quality management system by:
a) taking accountability for the effectiveness of the quality management
system;
b) ensuring that the quality policy and quality objectives are established for
the quality management system and are compatible with the context and
strategic direction of the organization;
c) ensuring the integration of the quality management system requirements
into the organization’s business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system
are available;
f) communicating the importance of effective quality management and of
conforming to the quality management system requirements;
g) ensuring that the quality management system achieves its intended
results;
h) engaging, directing and supporting persons to contribute to the
effectiveness of the quality management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their
leadership as it applies to their areas of responsibility?
5.2 Policy
5.2.1 Establishing the quality policy
Has top management established, implemented and maintained a quality policy
that:
a) is appropriate to the purpose and context of the organization and supports
its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality
management system?
Yes/No Evidence ________________________________________
6 Planning
6.1 Actions to address risks and opportunities
6.1.1
When planning for the quality management system, does the organization
consider the issues referred to in 4.1 and the requirements referred to in 4.2 and
determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its
intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement?
Are actions taken to address risks and opportunities proportionate to the potential
impact on the conformity of products and services?
6.2.2
When planning how to achieve its quality objectives, does the organization
determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated?
Yes/No Evidence ________________________________________
7 Support
7.1 Resources
7.1.1 General
Does the organization determine and provide the resources needed for the
establishment, implementation, maintenance and continual improvement of the
quality management system?
7.1.2 People
Does the organization determine and provide the persons necessary for the
effective implementation of its quality management system and for the operation
and control of its processes?
7.1.3 Infrastructure
Does the organization determine, provide and maintain the infrastructure
necessary for the operation of its processes and to achieve conformity of
products and services?
Yes/No Evidence ________________________________________
When addressing changing needs and trends, does the organization consider its
current knowledge and determine how to acquire or access any necessary
additional knowledge and required updates?
7.2 Competence
Does the organization:
a) determine the necessary competence of person(s) doing work under its
control that affects the performance and effectiveness of the quality
management system;
b) ensure that these persons are competent on the basis of appropriate
education, training, or experience;
c) where applicable, take actions to acquire the necessary competence, and
evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence?
7.4 Communication
Does the organization determine the internal and external communications
relevant to the quality management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates?
7.5.3.2
For the control of documented information, does the organization address the
following activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition;
e) prevention of the unintended use of obsolete documented
information by removal or by application of suitable identification or
controls if kept for any purpose? (AS9100D)
8 Operation
8.1 Operational planning and control
Does the organization plan, implement and control the processes (see 4.4)
needed to meet the requirements for the provision of products and services, and
to implement the actions determined in Clause 6, by:
a) determining the requirements for the products and services;
b) establishing criteria for:
1) the processes;
2) the acceptance of products and services;
c) determining the resources needed to achieve conformity to the product
and service requirements, and to meet on-time delivery of products
and services; (AS9100D)
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the
extent necessary:
1) to have confidence that the processes have been carried out as
planned;
2) to demonstrate the conformity of products and services to their
requirements;
f) determining the processes and controls needed to manage critical
items, including production process controls when key
characteristics have been identified;
g) engaging representatives of affected organization functions for
operational planning and control;
h) determining the process and resources to support the use and
maintenance of the products and services;
i) determining the products and services to be obtained from external
providers;
j) establishing the controls needed to prevent the delivery of
nonconforming products and services to the customer? (AS9100D)
Does the organization control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as
necessary?
Yes/No Evidence ________________________________________
Does the organization ensure that outsourced processes are controlled (see
8.4)?
Does the organization ensure that contract or order requirements differing from
those previously defined are resolved?
8.2.3.2
Does the organization retain documented information, as applicable:
a) on the results of the review;
b) on any new requirements for the products and services?
When appropriate, are design and development efforts divided into distinct
activities and, for each activity, are the tasks, necessary resources,
responsibilities, design content, and inputs and outputs defined?
(AS9100D)
Are inputs adequate for design and development purposes, complete and
unambiguous, and are conflicting design and development inputs resolved?
8.3.4.1 When tests are necessary for verification and validation, are these
tests planned, controlled, reviewed, and documented to ensure and prove
the following:
a) test plans or specifications identify the test item being tested and the
resources being used, define test objectives and conditions,
parameters to be recorded and relevant acceptance criteria;
b) test procedures describe the test methods to be used, how to
perform the test, and how to record the results;
c) the correct configuration of the test item is submitted for the test;
d) the requirements of the test plan and the test procedures are
observed;
e) the acceptance criteria are met? (AS9100D)
Has a process been implemented with criteria for notifying its customer,
prior to implementation, about changes that affect customer requirements?
(AS9100D)
Does the organization determine and apply criteria for the evaluation, selection,
monitoring of performance, and re-evaluation of external providers, based on
their ability to provide processes or products and services in accordance with
requirements, and does the organization retain documented information of these
activities and any necessary actions arising from the evaluations?
When external provider test reports are used to verify externally provided
products, is there a process to evaluate the data in the test reports to
confirm that the product meets requirements? (AS9100D)
Does the organization identify the status of outputs with respect to monitoring
and measurement requirements throughout production and service provision?
Does the organization control the unique identification of the outputs when
traceability is a requirement, and is documented information necessary to enable
traceability retained?
8.5.4 Preservation
Does the organization preserve the outputs during production and service
provision to the extent necessary to ensure conformity to requirements?
When problems are detected after delivery, does the organization take
appropriate action including investigation and reporting?
Does the release of products and services to the customer not proceed until the
planned arrangements have been satisfactorily completed, unless otherwise
approved by a relevant authority and, as applicable, by the customer, and is
documented information retained on the release of products and services?
Does the organization deal with nonconforming outputs in one or more of the
following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products
and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession by a relevant
authority and, when applicable, by the customer? (AS9100D)
8.7.2
Is documented information retained that:
a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity?
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
Does the organization determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation
needed to ensure valid results;
c) when the monitoring and measuring must be performed;
d) when the results from monitoring and measurement are to be analyzed
and evaluated?
Does the organization evaluate the performance and the effectiveness of the
quality management system and retain appropriate documented information as
evidence of the results?
Has the organization determined the methods for obtaining, monitoring and
reviewing this information?
9.2.2
Does the organization:
a) plan, establish, implement and maintain an audit program(s) including the
frequency, methods, responsibilities, planning requirements and reporting,
which take into consideration the importance of the processes concerned,
changes affecting the organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality
of the audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take appropriate correction and corrective actions without undue delay;
f) retain documented information as evidence of the implementation of the
audit program and the audit results?
10 Improvement
10.1 General
Does the organization determine and select opportunities for improvement and
implement any necessary actions to meet customer requirements and enhance
customer satisfaction, including:
a) improving products and services to meet requirements as well as to
address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management
system?
10.2.2
Is documented information retained as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action?
Are the results of analysis and evaluation, and the outputs from management
review, considered, to determine if there are needs or opportunities that must be
addressed as part of continual improvement?